Clinical trial · Observational

the Efficacy and Safety of CLAE in R/R T-ALL/LBL

Clinical Observation on the Efficacy and Safety of CLAE Regimen (Cladribine + Cytarabine + Etoposide) in the Treatment of Relapsed/Refractory T- Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma

NCT04679506CI-TRIAL-00049072unknownClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

To evaluate the efficacy and safety of CLAE regimen (cladribine + cytarabine + etoposide) in the treatment of relapsed/refractory T-ALL/LBL.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Precursor T-Cell Lymphoblastic Leukemia-Lymphoma	T Acute Lymphoblastic Leukemia	ALIAS	0.90

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Cladribine	Drug	Cladribine	ALIAS

Design

Arms and outcomes

Arms (0)

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Primary outcomes (1)

measure
ORR
timeFrame
From the date of first study drug administration until the end of Cycle 2 (each cycle is 28 days)
description
Objective response rate，sum of complete response rate and partial response rate

Secondary outcomes (2)

measure
PFS
timeFrame
From the date of first study drug administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.
description
progression-free survival
measure
OS
timeFrame
From the date of first study drug administration until the date of death due to any cause, assessed up to 24 months.
description
overall survival

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

* Diagnosis of T-acute lymphoblastic leukemia/lymphoblastic lymphoma according to World Health Organization (WHO) criteria which has relapsed or is refractory to chemotherapy.
* Age ≥ 18 years.
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
* The expected survival period is more than 12 weeks.
* At least one measurable nidus
* Adequate organ function defined as:

* Calculated creatinine clearance ≥ 50 ml/min using the cockcroft -Gault formula
* AST, ALT, total bilirubin ≤ 2 x upper limit of normal (ULN) except for Gilbert's disease or when in the opinion of treating physician elevated levels are due to direct involvement of leukemia (e.g., hepatic infiltration or biliary obstruction due to leukemia), in which case ALT and AST may be elevated up to ≤ 5 x ULN.
* Able to understand and willing to sign an Institutional Review Board (IRB)-approved written informed consent document.

Exclusion Criteria:

* Previous treatment with nelarabine or clofarabine or fludarabine or cladribine was ineffective.
* Pregnant or nursing.
* Received any other investigational agent or systemic cytotoxic chemotherapy within the preceding 2 weeks.
* Active HIV or hepatitis B or C infection.
* Any medical condition which, in the opinion of the clinical investigator, would interfere with the evaluation of the patient. Subjects with a clinically significant or unstable medical or surgical condition or any other condition that cannot be well-controlled by the allowed medications permitted in the study protocol that would preclude safe and complete study participation, as determined by medical history, physical examinations, laboratory tests, and according to the investigator's judgment.

References

Publications (0)

Data not yet available

No reference posted for this study.